BSD-500 HYPERTHERMIA SYSTEM
FDA premarket approval P820088/S017 · decided 2004-01-20
Approval details
- PMA number
- P820088
- Supplement
- S017
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- BSD-500 HYPERTHERMIA SYSTEM
- Generic name
- System, rf/microwave hyperthermia, cancer treatment
- Applicant
- Pyrexar Medical, Inc.
- Date received
- 2003-09-26
- Decision date
- 2004-01-20
- Days to decision
- 116 days
- Decision code
- APPR
- Product code
- LOC
- Advisory committee
- Radiology
- Expedited review
- No
- Location
- Salt Lake City, UT
- Statement
- APPROVAL TO REPLACE THE GENERATOR APPROVED IN PMA P820088/S005. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE SAME TRADE NAME, BSD-500 HYPERTHERMIA SYSTEM AND IS INDICATED FOR TREATMENT OF SOLID MALIGNANT TUMORS BY LOCALIZED HEAT DELIVERY.
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